E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients to be included in the study should experience wearing-off or other OFF periods and troublesome dyskinesia of at least four hours/day although they receive an individually optimised therapy with currently available oral anti-Parkinson drugs. An Off -period is defined as the time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. The term dyskinesia is used to describe involuntary, more or less fierce movements of limbs or |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The general objective in this study is to investigate the efficacy and safety of subcutaneously applied Lisparin given as a continuous infusion as add-on medication in levodopa-treated patients with Parkinson s diseases and motor complications with no or poor response to standard therapy. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to investigate further the effect of study treatment in an explorative manner. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male or Female patients Age 18 - 75 years Idiopathic Parkinson s disease for at least 3 years diagnosis based on the UK Brain Bank Criteria and with Presence of Motor fluctuations wearing-off or other OFF periods and / or presence of troublesome dyskinesia, with a total daily minimum of at least 4 hours, despite optimized oral anti-parkinsonian therapy Stable levodopa intake, i.e. at least four doses of levodopa per day Stable dosing of all other anti-parkinsonian drugs, such as dopamine agonists, COMT- and MAO-B inhibitors, amantadine, or anticholinergics for a minimum of four weeks prior to inclusion. The following oral dopamine agonist drugs are allowed in this trial pramipexol up to a total daily dose of 3,15mg, ropinirol up to a total daily dose of 24mg, cabergoline up to a total daily dose of 6mg or combinations Concomitant diseases are stable and well controlled Willingness and ability to comply with all trial requirements Written informed consent |
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E.4 | Principal exclusion criteria |
Non-idiopathic Parkinson s disease e.g. drug-induced or other forms of secondary or atypical parkinsonism such as multiple system atrophy, MSA Significant neurological symptoms not accounted for by Parkinson s disease History or presence of dementia, demonstrated by the Mini-mental status examination MMSE 24 Presence of major depression according to DSM IV criteria 8805; 6 months History or presence of epilepsy Presence of dopaminergic psychosis Unstable severe concomitant diseases e.g. liver diseases, kidney diseases, or clinically relevant cardiac or coronary dysfunction Presence of heart valvular fibrosis or indication of significant valvular stenosis / insufficiency on echocardiogram History of syncope and/or severe otherwise symptomatic orthostatic hypotension Present treatment with neuroleptics, including atypical neuroleptics Treatment with other CNS active drug therapy e.g. sedatives, hypnotics, anti-depressants, anxiolytics unless the dose has been stable for at least four weeks prior to the baseline visit Participation in another trial of an investigational drug within the last 28 days or current participation in another trial of an investigational drug Clinically significant laboratory abnormalities Previous neurosurgery in Parkinson s disease Alcohol or drug abuse in the past three years Women of childbearing potential without adequate and effective form of birth control with a Pearl index 1 e.g. abstinence, hormonal contraception, hormonal IUD Pregnancy or lactation Known hypersensitivity to Lisurid, Ropinirole, Pramipexol, Cabergoline, or other ergoline substances. History of pleural effusion or fibrosis or acute pulmonary fibrosis. Raynaud-syndrome Known gastro-intestinal ulcers or bleedings Clinically significant liver failure total bilirubin 2.0 mg/dl or SGOT and/or SGPT greater than two times the upper limit of the reference range Clinically relevant renal dysfunction serum creatinine 2.0 mg/dl QTc interval 470 msec at screening ECG Co-medication with drugs prolonging the QTc interval, e.g. oral ketoconalzole or other inhibitors of the cytocrome system Other known risk factors for Torsades de Pointes arrhythmias e.g. cardiac insufficiency NYHA II-IV, hypokalemia, hereditary long-QT-syndrome |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total daily OFF-time and ON-time with troublesome dyskinesia based on patient s diaries comparison between double-blind treatment with Lisparin or placebo with regard to changes from Baseline B0 to T6. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |